| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00156-1 |
| Product Name/Description |
HACTIV Calcar reamers
Part Numbers: H01 058 - Calcar reamer 40 Harris connect - Hyperion
Batch Numbers: P1605804, P17061051
Part Numbers: H01 060 - Calcar reamer 48 Harris connect - Hyperion
Batch Numbers: P16051337, P1605805
ARTG Number: 157418
(Amplitude Australia - Prosthetic joint implantation kit) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Amplitude Australia has been notified by the manufacturer, Evolutis, that certain batches of the calcar reamer show a defect in the sharpening of the teeth. |
| Recall Action |
Recall |
| Recall Action Instructions |
Amplitude is advising that unaffected reamers are expected to be available 15th March 2018. Amplitude will arrange exchange of affected units from users.
This action has been closed out on 09/07/2019 |
| Contact Information |
02 8015 7914 - Customer Service Support |